Ischemic Preconditioning Claudication Study

Medical College of Wisconsin24 enrolled

Overview

This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication.

This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a circulatory condition in which large supply blood vessels narrow, reducing oxygen and nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by ischemia and can improve functional capacity in patients recovering from stroke; however, the benefit of ischemic preconditioning in patients with peripheral arterial disease remains unclear. The investigators predict that ischemic preconditioning (IPC) will delay claudication onset time (COT), increase peak walking time (PWT) and improve muscle strength in patients with intermittent claudication. The investigators will determine whether IPC improves claudication onset time (COT) and peak walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be employed to assess COT and PWT. The investigators will determine whether IPC can improve muscle strength and time to pain onset in the affected leg of patients with intermittent claudication. These metrics will be assessed quantitatively using a Biodex™ dynamometer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intermittent Claudication Ischemia Vascular Peripheral Arterial Disease Peripheral Vascular Disease

Interventions

Ischemic PreconditioningOTHER

See Ischemic Preconditioning Experimental group description

Control GroupOTHER

See Control group description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. between ages of 18-80 2. able to give informed consent 3. presence of vascular disease with intermittent claudication Exclusion Criteria: 1. age \< 18 or \>80 2. unable to give informed consent 3. presence of vascular disease with leg pain at rest, ischemic ulceration, or gangrene 4. pregnancy 5. unable to walk on a treadmill 6. unable to perform or tolerate ischemic preconditioning 7. unable to follow commands 8. exercise capacity limited by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, or arthritis to be determined by PI 9. patients who have undergone vascular surgery or endovascular surgery in the previous year on the affected leg 10. history of major lower extremity amputation 11. history of major psychiatric disorder 12. history of uncontrolled hypertension

Locations (1)

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Peak walking time

Subjects will be placed on a motorized treadmill and peak walking time will be recorded in seconds.

Time frame: 2 weeks

Secondary Outcomes

Muscle Fatigue

Subjects will perform muscle contractions for muscle groups of interest (knee extensors/flexors and dorsiflexors/plantarflexors). Contractions will be measured in newton-meters. The duration will be determined by the time subjects first feel pain and when the pain becomes too great to continue. The investigators will provide subjects with visual feedback on the monitor throughout the testing.

Time frame: 2 weeks

Claudication onset time

Subjects will be placed on a motorized treadmill and claudication onset time will be recorded in seconds.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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